Over the past two decades, there have been transformative changes in our approach to using modelling & simulation (M&S) to assess and manage drug–drug interactions (DDIs) involving CYP enzymes and…
Next generation therapeutics Oligonucleotide drugs are unique among therapeutic modalities in that they don’t engage the disease modulating proteins directly but instead target their encoding mRNA (read more about how…
Gain a foundational understanding of QSP in this 101-level article with examples of QSP applied to Immunogenicity, Immuno-Oncology, and other areas.
Historically, the dosing strategy for oncology drugs focused on the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being…
“Quantitative decision-making with data rather than empirical thinking” – Certara’s Modeling & Simulation technology contributes to accelerate new drug development Certara G.K. held an online press seminar on Wednesday, August…
Human mass-balance studies are also called “C-14 studies” or “Absorption, Metabolism, and Excretion (AME) studies.” Drug developers conduct these studies of radiolabeled drugs to quantify the routes of elimination of…
R&D World editors, Paul Heney and Aimee Kalnoskas, have their minds blown — multiple times! — in this June 2022 Podcast, which delves into Certara’s Simcyp COVID-19 Vaccine Model, a…
Physiologically-based pharmacokinetic (PBPK) modeling is a technique used to predict the absorption, distribution, metabolism, and excretion (ADME) of chemicals in both humans and animal populations. The use of PBPK modeling…
Innovative PBPK software that supports screening, first-in-human dose prediction, early DDI and formulation decisions.
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus. With deep experience in model-informed oncology drug development, dosing and regulatory strategy and submission, we’ve helped advance hundreds of…
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